Morselized Osteotomy, Subscapularis Peel
Conditions
Keywords
Osteoarthritis, Shoulder, subscapularis peel, osteotomy
Brief summary
This pilot study is being conducted to compare 2 methods of access to the shoulder for arthroplasty in patients with Osteoarthritis as we do not know has a better outcome.
Detailed description
The study investigates the difference in disease specific quality of life between patients who undergo a subscapularis peel versus morselized osteotomy of the lesser tuberosity, as measured by the Western Ontario Osteoarthritis of the Shoulder (WOOS) at one year post-operatively in patients who undergo shoulder arthroplasty ?
Interventions
PROCEDUREsubscapularis peel
Detachment of the subscapularis tendon from its insertion on the lesser tuberosity the peel.
PROCEDUREosteotomy
This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder.
Sponsors
Ottawa Hospital Research Institute
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Patients who have failed standard non-surgical management of their shoulder arthritis who would benefit from a shoulder arthroplasty.
Exclusion criteria
* Active joint or systemic infection * Significant muscle paralysis * Rotator cuff tear arthroplasty * Major medical illness * Unable to speak or read English/French * Psychiatric illness that precludes informed consent * Unwilling to be followed for 1 year
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Subscapularis Strength | 2 years | Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Western Ontario Osteoarthritis of the Shoulder Index | 2 Years | The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome. |
| American Shoulder and Elbow Score | 2 Years | The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome. |
Countries
Canada
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Subscapularis Peel Detachment of the subscapularis tendon from its insertion on the lesser tuberosity the peel. | 44 |
| Osteotomy osteotomy: This group will use a technique that involves elevation of the tendon with a wafer of bone in order to gain access to the shoulder. | 43 |
| Total | 87 |
Baseline characteristics
| Characteristic | Osteotomy | Total | Subscapularis Peel |
|---|---|---|---|
| Age, Categorical <=18 years | 0 Participants | 0 Participants | 0 Participants |
| Age, Categorical >=65 years | 32 Participants | 49 Participants | 17 Participants |
| Age, Categorical Between 18 and 65 years | 11 Participants | 38 Participants | 27 Participants |
| Age, Continuous | 65.3 years | 67.8 years | 70.4 years |
| Race and Ethnicity Not Collected | — | 0 Participants | — |
| Region of Enrollment Canada | 43 Participants | 87 Participants | 44 Participants |
| Sex: Female, Male Female | 27 Participants | 53 Participants | 26 Participants |
| Sex: Female, Male Male | 16 Participants | 34 Participants | 18 Participants |
Adverse events
| Event type | EG000 affected / at risk | EG001 affected / at risk |
|---|---|---|
| deaths Total, all-cause mortality | — / — | — / — |
| other Total, other adverse events | 0 / 44 | 0 / 43 |
| serious Total, serious adverse events | 0 / 44 | 0 / 43 |
Outcome results
Primary
Subscapularis Strength
Subscapularis muscle strength will be measured with an electronic handheld dynamometer. Patients are asked to press the dynamometer in towards their chest (belly-press) for a period of approximately 3 seconds before releasing. Strength is measured in kilograms of force.
Time frame: 2 years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osteotomy | Subscapularis Strength | 4.4 kg | Standard Deviation 2.9 |
| Subscapularis Peel | Subscapularis Strength | 5.5 kg | Standard Deviation 2.6 |
Secondary
American Shoulder and Elbow Score
The ASES is a shoulder specific assessment divided into two sections: pain and activities of daily living (ADL). Pain is recorded on a visual analogue scale (0-10), lower scores indicate better outcomes. There are 10 activities of daily living questions, each are recorded on a 4 level likert scale (0-3), which a higher score indicates a better outcome. The overall score is an equal weight of the two sections and produces a score out of 100. The higher the score, the better the outcome.
Time frame: 2 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osteotomy | American Shoulder and Elbow Score | 79.4 ASES Score | Standard Deviation 24.6 |
| Subscapularis Peel | American Shoulder and Elbow Score | 83.3 ASES Score | Standard Deviation 19 |
Secondary
Western Ontario Osteoarthritis of the Shoulder Index
The Western Ontario Osteoarthritis of the Shoulder Index (WOOS) is a disease specific evaluation, proven to be an accurate and valid assessment of function after shoulder replacement. The WOOS is a patient-reported measure, 19-question survey. Each question is measured using a visual analog scale rated from 0-100, where higher scores mean better outcome.
Time frame: 2 Years
| Arm | Measure | Value (MEAN) | Dispersion |
|---|---|---|---|
| Osteotomy | Western Ontario Osteoarthritis of the Shoulder Index | 86.5 WOOS Score | Standard Deviation 16 |
| Subscapularis Peel | Western Ontario Osteoarthritis of the Shoulder Index | 88.2 WOOS Score | Standard Deviation 16.5 |